Registrants (1)
Strides Pharma Global Pte. Ltd.
659220961
Manufacturing Establishments (1)
Strides Pharma, Inc
Strides Pharma Science Limited
Strides Pharma Global Pte. Ltd.
118344504
Products (2)
Omeprazole/Sodium Bicarbonate
64380-183
ANDA079182
ANDA (C73584)
ORAL
September 21, 2023
OmeprazoleActive
Code: KG60484QX9Class: ACTIBQuantity: 40 mg in 1720 mg
XYLITOLInactive
Code: VCQ006KQ1EClass: IACT
Sodium bicarbonateActive
Code: 8MDF5V39QOClass: ACTIBQuantity: 1680 mg in 1720 mg
XANTHAN GUMInactive
Code: TTV12P4NEEClass: IACT
PEACHInactive
Code: 3OKE88I3QGClass: IACT
PEPPERMINTInactive
Code: V95R5KMY2BClass: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4Class: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
Omeprazole/Sodium Bicarbonate
64380-182
ANDA079182
ANDA (C73584)
ORAL
September 21, 2023
OmeprazoleActive
Code: KG60484QX9Class: ACTIBQuantity: 20 mg in 1700 mg
Sodium bicarbonateActive
Code: 8MDF5V39QOClass: ACTIBQuantity: 1680 mg in 1700 mg
XYLITOLInactive
Code: VCQ006KQ1EClass: IACT
XANTHAN GUMInactive
Code: TTV12P4NEEClass: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4Class: IACT
PEACHInactive
Code: 3OKE88I3QGClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
PEPPERMINTInactive
Code: V95R5KMY2BClass: IACT